FDA Medical Device Recalls (openFDA)
Medtronic Minimally Invasive Therapies Group: Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.
- Recall number
- Z-0936-2018
- Recalling firm
- Medtronic Minimally Invasive Therapies Group
- Product
- Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.
- Status
- Terminated
- Initiated
- 2017-10-24
- Posted
- 2018-03-05
- Terminated
- 2020-10-26
- Reason
- Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
- Root cause
- Packaging process control
- Action
- An URGENT MEDICAL DEVICE RECALL letter was issued to customers on October 24, 2017. This letter notified customers of the products subject to the recall and stated the following: The primary package labeling (Label closest to the product) may be incorrect. Customers can identify the affected product by consulting Attachment B. Please quarantine and return any unused products of the item codes and lot detailed above. Unused products from the affected item code and lots should be returned as described in the Required Actions section below. If you have distributed the Argyle" Suction tubing listed above, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes and lots must be returned. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
- Quantity
- 58,954
- Distribution
- USA (nationwide) Distribution
- Lot, serial or model codes
- 710016864X
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAZ
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28